How Products were Selected:
Products were selected to represent those commonly sold and/or available nationally in the U.S. and Canada. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, catalogues, or multi-level marketing companies. Products were not accepted directly from manufacturers.
Testing Methods:
Omega-3 marine oil capsules and liquids were tested for identity and amounts of EPA, DHA and other claimed fatty acids, freshness (peroxide value, anisidine value, and TOTOX) and potential contamination with mercury, lead, and PCBs. Optional dioxin testing.
All products were assessed in independent laboratories using the following methods: for EPA, DHA and other fatty acids components by gas chromatography utilizing a modified AOAC method (Association of Official Analytical Chemists, International; Official Method 991.39); for peroxide value using AOCS method (American Oil Chemists Society; Method CD 8-53 or similar); for anisidine value using AOCS method (Method CD 18-90 or similar); for mercury using a Cold Vapor Atomic Absorption method; for PCBs using High Resolution Gas Chromatography coupled with High Resolution Mass Spectrometry (EPA Method 1668A); and for lead using ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy). Optional dioxin testing was performed using EPA method 1663B.
Products not passing the initial assay for EPA, DHA and other fatty acids, peroxide value, anisidine value, TOTOX and/or mercury or lead were tested in another independent laboratory utilizing a similar method.
Disintegration of enteric-coated formulations were analyzed utilizing USP (United States Pharmacopeia) <701> recommendations.
The identities of the products were not disclosed to the laboratories performing the testing.
Passing Score: * To achieve a "Pass" in the testing a product, whether for human or pet use, must meet the following criteria:
Contain 100% and not exceed 150% of the claimed amounts of EPA, DHA or other fatty acids.
Have a peroxide value (PV) of no more than 5 meq/kg, an anisidine value (AV) of no more than 20, and a TOTOX value of no more than 26 (calculated as (2 x PV) + AV) (GOED Monograph Recommendation).
Contain less than 0.1 ppm of mercury (GOED Monograph Recommendation).
Meet the State of California's Prop 65 limits for lead in supplements: 0.5 mcg of lead per daily serving with an additional allowance of 1.0 mcg for supplements containing 1,000 mg/day or more of elemental calcium and 0.5 mcg for supplements containing specific other minerals. For supplements not marketed for use by children, ConsumerLab.com provides an additional allowance of 0.5 mcg if containing 250 to 499 mg/day of elemental calcium or 1.0 mcg if containing 500 to 999 mg/day of elemental calcium and an allowance of 0.5 mcg for if containing one whole herb (not extract) ingredient or 1.0 mcg for two or more whole herb ingredients. If a maximum recommended daily serving is not defined, a daily serving size will be determined and applied by CL.
Dioxin-like PCBs include the sum of 4 individual non-ortho PCBs and 8 mono-ortho PCBs. For non-concentrated fish body oils (<80% EPA & DHA (%wt/wt)) a limit of 3pg/g. (GOED) For fish body oil concentrates (> 80%), fish liver oil and oil from other marine organisms a limit of 6 pg/g. (proposed EU).
If tested for dioxins: Total dioxin of no more than 1.5 pg WHO-PCDD/F-TEQ/g. Dioxin limit includes the sum of 17 individual congeners (dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)) defined by the WHO-toxic equivalent factors expressed as TEQ for all marine oils (fish body oils, fish liver oil and oil from other marine organisms) (proposed EU).
Meet recommended USP disintegration parameters for enteric coated capsules (excluding regular capsules, chewable and time-release products).
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
* Passing scores allow for specific margins of technical error associated with each analysis. ConsumerLab.com reserves the right to disqualify a product at any time from passing its testing if it considers such product to present a safety risk or to provide misleading or inaccurate information in its labeling.
